Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 86343 

Portal: https://www.accessdata.fda.gov/ 

scripts/FACTRSPortal/FACTRS/ 

index.cfm or by mail to Advisory 

Committee Oversight and Management 

Staff, 10903 New Hampshire Ave., Bldg. 

32, Rm. 5122, Silver Spring, MD 20993– 

0002. Additional information about 

becoming a member of an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT:

For questions relating to participation 

in the selection process: Kimberly 

Hamilton, Advisory Committee 

Oversight and Management Staff, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 5122, 

Silver Spring, MD 20993–0002, 301– 

796–8220, kimberly.hamilton@

fda.hhs.gov. 

For questions relating to the Genetic 

Metabolic Diseases Advisory Committee: 

Moon Choi, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–2894, 

GEMDAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for a voting 

consumer representative on the Genetic 

Metabolic Diseases Advisory 

Committee. Elsewhere in this Federal 

Register, FDA is publishing separate 

documents regarding: 

1. Genetic Metabolic Diseases Advisory 

Committee; Notice of Establishment 

2. Request for Nominations for Voting 

Members on a Public Advisory 

Committee: Genetic Metabolic 

Diseases Advisory Committee 

3. Request for Nominations of 

Individuals and Industry 

Organizations for the Genetic 

Metabolic Diseases Advisory 

Committee 

I. Function and General Description of 

the Committee Duties 

Genetic Metabolic Diseases Advisory 

Committee 

The Committee reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational human 

drug and biologic products for use in 

the treatment of genetic metabolic 

diseases and makes appropriate 

recommendations to the Commissioner 

of Food and Drugs. 

II. Criteria for Members 

Persons nominated for membership as 

a consumer representative on this 

committee should meet the following 

criteria: (1) demonstrate an affiliation 

with and/or active participation in 

consumer or community-based 

organizations, (2) be able to analyze 

technical data, (3) understand research 

design, (4) discuss benefits and risks, 

and (5) evaluate the safety and efficacy 

of products under review. The 

consumer representative should be able 

to represent the consumer perspective 

on issues and actions before the 

advisory committee; serve as a liaison 

between the committee and interested 

consumers, associations, coalitions, and 

consumer organizations; and facilitate 

dialogue with the advisory committees 

on scientific issues that affect 

consumers. 

III. Selection Procedures 

Selection of members representing 

consumer interests is conducted 

through procedures that include the use 

of organizations representing the public 

interest and public advocacy groups. 

These organizations recommend 

nominees for the Agency’s selection. 

Representatives from the consumer 

health branches of Federal, State, and 

local governments also may participate 

in the selection process. Any consumer 

organization interested in participating 

in the selection of an appropriate voting 

member to represent consumer interests 

should send a letter stating that interest 

to FDA (see ADDRESSES) within 30 days 

of publication of this document. 

Within the subsequent 60 days, FDA 

will compile a list of consumer 

organizations that will participate in the 

selection process and will forward to 

each such organization a ballot listing at 

least two qualified nominees selected by 

the Agency based on the nominations 

received, together with each nominee’s 

current curriculum vitae or re ́sume ́. 

Ballots are to be filled out and returned 

to FDA within 30 days. The nominee 

receiving the highest number of votes 

ordinarily will be selected to serve as 

the member representing consumer 

interests for that particular advisory 

committee. 

IV. Nomination Procedures 

Any interested person or organization 

may nominate one or more qualified 

persons to represent consumer interests 

on the Genetic Metabolic Diseases 

Advisory Committee with the exception 

of the following: Individuals who are 

not U.S. citizens or nationals cannot be 

appointed as advisory committee 

members (42 U.S.C. 217(a)) in FDA. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business and/or home address, 

telephone number, and email address if 

available; a signed copy of the 

Acknowledgment and Consent form 

available at the FDA Advisory 

Nomination Portal (see ADDRESSES); and 

a list of consumer or community-based 

organizations for which the candidate 

can demonstrate active participation. 

Nominations should also specify the 

advisory committee for which the 

nominee is recommended. In addition, 

nominations must also acknowledge 

that the nominee is aware of the 

nomination, unless self-nominated. FDA 

will ask potential candidates to provide 

detailed information concerning such 

matters related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflicts of interest. 

Members will be invited to serve for 

terms up to 4 years. 

FDA will review all nominations 

received within the specified 

timeframes and prepare a ballot 

containing the names of qualified 

nominees. Names not selected will 

remain on a list of eligible nominees 

and be reviewed periodically by FDA to 

determine continued interest. After 

selecting qualified nominees for the 

ballot, FDA will provide those 

consumer organizations that are 

participating in the selection process 

with the opportunity to vote on the 

listed nominees. Only organizations 

vote in the selection process. Persons 

who nominate themselves to serve as 

voting consumer representatives will 

not participate in the selection process. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.) and 21 CFR part 14, 

relating to advisory committees. 

Dated: December 7, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27302 Filed 12–12–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–1506] 

Methodological Challenges Related to 

Patient Experience Data; Summary of 

Received Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a summary on the 

comments received for the 

‘‘Methodological Challenges Related to 


khammond on DSKJM1Z7X2PROD with NOTICES
86344 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 

1The Federal Food, Drug, and Cosmetic Act, as 

amended by the 21st Century Cures Act (Pub. L. 

114–255) and the FDA Reauthorization Act of 2017 

(FDARA) (Pub. L. 115–52), defines patient 

experience data as data that are collected by any 

persons (including patients, family members and 

caregivers of patients, patient advocacy 

organizations, disease research foundations, 

researchers and drug manufacturers) and are 

intended to provide information about patients’ 

experiences with a disease or condition, including 

the impact (including physical and psychosocial 

impacts) of such disease or condition or a related 

therapy or clinical investigation and patient 

preferences with respect to treatment of the disease 

or condition. 

Patient Experience Data; Request for 

Information and Comments’’ notice 

published on May 2, 2023. The input 

received in response to the Request for 

Information will help FDA plan two 

public workshops focused on 

methodological challenges and will help 

FDA identify priorities for future work. 

FOR FURTHER INFORMATION CONTACT: 

Ethan Gabbour, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6306, 

Silver Spring, MD 20993, 301–796– 

8112, Ethan.Gabbour@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background

Under the seventh iteration of the

Prescription Drug User Fee Act, 

incorporated as part of the FDA User 

Fee Reauthorization Act of 2022, FDA 

committed to facilitate the advancement 

and use of systematic approaches to 

collect and utilize robust and 

meaningful patient and caregiver input 

that can more consistently inform drug 

development and, as appropriate, 

regulatory decision making. This 

included issuing a Request for 

Information (RFI) available at https://

www.federalregister.gov/documents/ 

2023/05/02/2023-09265/ 

methodological-challenges-related-topatient-experience-data-request-forinformation-and-comments to elicit 

public input on methodologic 

challenges related to patient experience 

data encountered by stakeholders, and 

other areas of greatest interest or 

concern to public stakeholders.1 The 

RFI was published on May 2, 2023, and 

the public comment period was open 

until July 3, 2023. A summary of the 

comments received can be found in the 

in the public docket or by going to 

https://www.regulations.gov and 

entering the following docket number: 

FDA–2023–N–1506. 

II. Electronic Access

Persons with access to internet may

obtain the summary within the public 

docket at https://www.regulations.gov/ 

docket/FDA-2023-N-1506. 

Dated: December 8, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27312 Filed 12–12–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4917] 

Advisory Committee; Genetic 

Metabolic Diseases Advisory 

Committee; Establishment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of establishment. 

SUMMARY: Under the Federal Advisory 

Committee Act, the Food and Drug 

Administration (FDA) is announcing the 

establishment of the Genetic Metabolic 

Diseases Advisory Committee. The 

Commissioner of Food and Drugs 

(Commissioner) has determined that it 

is in the public interest to establish such 

a committee. Duration of this committee 

is 2 years from the date the Charter is 

filed, unless the Commissioner formally 

determines that renewal is in the public 

interest. 

DATES: Either electronic or written 

comments on the notice must be 

submitted by February 12, 2024. FDA is 

establishing a docket for public 

comment on this document. The docket 

number is FDA–2023–N–4917. The 

docket will close on February 12, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 12, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal:

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–N–4917 for ‘‘Advisory Committee; 

Genetic Metabolic Diseases Advisory 

Committee; Establishment.’’ Received 

comments, those filed in a timely 

manner, will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ FDA 

will review this copy, including the 

claimed confidential information, in its 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information be made publicly 

available, you can provide this 

information on the cover sheet and not 


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